BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 20062858 · Received August 26, 2024

    Report

    Report Number
    3005180920-2024-00646
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JULY 2024 LOT 2114768: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2022. EXPIRATION DATE: 2027-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: BATCH REVIEW (PERFORMED ON 31 JULY 2024) FOR GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L (K140826) LOT 2116091: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2027-01-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN DUE TO A NICKEL ALLERGY. AT ABOUT 2 YEARS POST PRIMARY THE SURGEON REVISED ALL COMPONENTS TO SENSITIN COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294023 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2114768 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention